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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMODELS PC10 & PC21
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
SANTA ANA, CA 92705
PMA NumberP820049
Date Received07/08/1982
Decision Date05/17/1983
Withdrawal Date 07/25/2006
Product Code HQL 
Docket Number 83M-0174
Notice Date 06/17/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S064 
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